Medical Device Sterilization and Disinfection Quiz

The absence of any living microorganisms, including bacteria, viruses, fungi, and spores.

A process where the final sterilization step is performed after all manufacturing and packaging procedures are completed.

A technique used to produce and maintain a sterile environment, ensuring that the product remains free of microorganisms throughout the manufacturing process.

The number and types of microorganisms present on a product, which may include bacteria, viruses, fungi, and spores.

A material is considered either sterile (free of microorganisms) or non-sterile (containing microorganisms). There is no in-between state.

Terminal sterilization methods are often not feasible for devices containing biologics or liquids because these components can be damaged by the sterilization process.

When terminal sterilization is not possible, aseptic processing techniques are used to ensure that the device remains sterile throughout its manufacture and packaging.

Biologics and liquids can interfere with the effectiveness of terminal sterilization methods. For example, heat sterilization can denature proteins in biologics, while chemical sterilization might not be compatible with certain liquids.

The most common sterilization practices involve treating a product or device after it's been completely manufactured and packaged. These methods target the final product.

The term sterile, from a regulatory perspective, signifies the probability of an implant or device containing viable microorganisms. Though a device may be labeled sterile, it is not necessarily guaranteed to be completely free of microorganisms.